70180 Federal Register / Vol. 85, No. 214 / Wednesday, November 4, 2020 / Notices

ANNUAL BURDEN ESTIMATES

Total number Total number of responses Average Total burden Annual burden Instrument of respondents per respond- burden hours hours hours ent per response

Refugee Data Submission for Formula Funds Allocations (ORR–5)—Current (through January 31, 2021) ...... 50 1 90 4,500 * 1,500 Refugee Data Submission for Formula Funds Allocations (ORR–5)—Revised ...... 50 3 140 21,000 7,000 * Burden is annualized over the full 3-year request period, but this form will be complete within the 1st year.

Estimated Total Annual Burden FOR FURTHER INFORMATION CONTACT: Director may grant an exception or Hours: 8,500. Domini Bean, Office of Operations, alternative to certain FDA labeling Authority: 8 U.S.C. 412(a)(3). Food and Drug Administration, Three requirements if compliance with these White Flint North, 10A–12M, 11601 labeling requirements could adversely Mary B. Jones, Landsdown St., North Bethesda, MD affect the safety, effectiveness, or ACF/OPRE Certifying Officer. 20852, 301–796–5733, PRAStaff@ availability of products that are or will [FR Doc. 2020–24398 Filed 11–3–20; 8:45 am] fda.hhs.gov. be included in the SNS. An exception BILLING CODE 4184–45–P SUPPLEMENTARY INFORMATION: In or alternative granted under the compliance with 44 U.S.C. 3507, FDA regulations may include conditions or has submitted the following proposed safeguards so that the labeling for such DEPARTMENT OF HEALTH AND collection of information to OMB for products includes appropriate HUMAN SERVICES review and clearance. information necessary for the safe and effective use of the product given the Food and Drug Administration Exceptions or Alternatives to Labeling product’s anticipated circumstances of Requirements for Products Held by the use. Any grant of an exception or [Docket No. FDA–2010–N–0588] Strategic National Stockpile alternative will only apply to the OMB Control Number 0910–0614— specified lots, batches, or other units of Agency Information Collection Extension medical products in the request. The Activities; Submission for Office of appropriate FDA Center Director may Under the Public Health Service Act, Management and Budget Review; also grant an exception or alternative to the Department of Health and Human Comment Request; Exceptions or the labeling provisions specified in the Alternatives to Labeling Requirements Services stockpiles medical products that are essential to the health security regulations on his or her own initiative. for Products Held by the Strategic Under §§ 201.26(b)(1)(i) (human drug National Stockpile of the Nation (see 42 U.S.C. 247d–6b). This collection of medical products for products), 610.68(b)(1)(i) (biological AGENCY: Food and Drug Administration, use during national health emergencies, products), 801.128(b)(1)(i) (medical HHS. known as the Strategic National devices), and 809.11(b)(1)(i) (in vitro diagnostic products for human use) an ACTION: Notice. Stockpile (SNS), is to provide for the emergency health security of the United SNS official or any entity that manufactures (including labeling, SUMMARY: The Food and Drug States, including the emergency health Administration (FDA) is announcing security of children and other packing, relabeling, or repackaging), that a proposed collection of vulnerable populations, in the event of distributes, or stores such products that information has been submitted to the a bioterrorist attack or other public are or will be included in the SNS may Office of Management and Budget health emergency. submit, with written concurrence from (OMB) for review and clearance under It may be appropriate for certain a SNS official, a written request for an the Paperwork Reduction Act of 1995 medical products that are or will be exception or alternative to certain (PRA). held in the SNS to be labeled in a labeling requirements to the appropriate manner that would not comply with FDA Center Director. Except when DATES: Submit written comments certain FDA labeling regulations given initiated by an FDA Center Director, a (including recommendations) on the their anticipated circumstances of use in request for an exception or alternative collection of information by December an emergency. However, noncompliance must be in writing and must: 4, 2020. with these labeling requirements could • Identify the specified lots, batches, ADDRESSES: To ensure that comments on render such products misbranded under or other units of the affected product; the information collection are received, section 502 of the Federal Food, Drug, • identify the specific labeling OMB recommends that written and Cosmetic Act (21 U.S.C. 352). provisions under the regulations that are comments be submitted to https:// Under §§ 201.26, 610.68, 801.128, and the subject of the request; www.reginfo.gov/public/do/PRAMain. 809.11 (21 CFR 201.26, 610.68, 801.128, • explain why compliance with the Find this particular information and 809.11), the appropriate FDA Center specified labeling provisions could collection by selecting ‘‘Currently under Director may grant a request for an adversely affect the safety, effectiveness, Review—Open for Public Comments’’ or exception or alternative to certain or availability of the product subject to by using the search function. The OMB regulatory provisions pertaining to the the request; control number for this information labeling of human drugs, biological • describe any proposed safeguards or collection is 0910–0614. Also include products, medical devices, and in vitro conditions that will be implemented so the FDA docket number found in diagnostics that currently are or will be that the labeling of the product includes brackets in the heading of this included in the SNS if certain criteria appropriate information necessary for document. are met. The appropriate FDA Center the safe and effective use of the product

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given the anticipated circumstances of information collection provisions in prepare a supplement to an application, use of the product; §§ 314.70, 601.12, 807.81, and 814.39 which may be considered similar to a • provide copies of the proposed have been approved under OMB control request for an exception or alternative. labeling of the specified lots, batches, or numbers 0910–0001, 0910–0338, 0910– To the extent that labeling changes not other units of the affected product that 0120, and 0910–0231, respectively. On already required by FDA regulations are will be subject to the exception or a case-by-case basis, the appropriate made in connection with an exception alternative; and FDA Center Director may also determine or alternative granted under the • provide any other information when an exception or alternative is regulations, FDA is estimating one requested by the FDA Center Director in granted that certain safeguards and occurrence annually in the event FDA support of the request. conditions are appropriate, such as would require any additional labeling If the request is granted, the additional labeling on the SNS changes not already covered by FDA manufacturer may need to report to FDA products, so that the labeling of such regulations. FDA estimates 8 hours to any resulting changes to the new drug products would include information develop and revise the labeling to make application, biologics license needed for safe and effective use under such changes. The average burden per application, premarket approval the anticipated circumstances of use. response for each submission is based application, or premarket notification Respondents to this collection of on the estimated time to develop and (510(k)) in effect, if any. The submission information are entities that revise the labeling to make such and grant of an exception or an manufacture (including labeling, changes. alternative to the labeling requirements packing, relabeling, or repackaging), In the Federal Register of July 2, 2020 specified in the regulations may be used distribute or store affected SNS (85 FR 39914), FDA published a 60-day to satisfy certain reporting obligations products. Based on data from fiscal notice requesting public comment on relating to changes to product years 2017, 2018, and 2019, FDA the proposed collection of information. applications under §§ 314.70, 601.12, estimates an average of one request One comment was received but was not 814.39, or 807.81 (21 CFR 314.70 annually for an exception or alternative responsive to the four information (human drugs), 601.12 (biological received by FDA. FDA estimates an collection topics solicited and is products), 814.39 (medical devices average of 24 hours preparing each therefore not addressed in this subject to premarket approval), or request. The average burden per document. 807.81 (medical devices subject to response for each submission is based FDA estimates the burden of this 510(k) clearance requirements)). The on the estimated time that it takes to collection of information as follows:

TABLE 1—ESTIMATED ANNUAL REPORTING BURDEN 1

Average Number of Number of Total annual burden 21 CFR Section respondents responses per responses per response Total hours respondent (in hours)

201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and 809.11(b)(1)(i) ...... 1 1 1 24 24 201.26(b)(1)(i), 610.68(b)(1)(i), 801.128(b)(1)(i), and 809.11(b)(1)(i) ...... 1 1 1 8 8

Total ...... 32 1 There are no capital costs or operating and maintenance costs associated with this collection of information.

Consistent with the PRA, our current DEPARTMENT OF HEALTH AND DATES: Submit written comments estimate of the burden of the HUMAN SERVICES (including recommendations) on the information collection is based on our collection of information by December evaluation over the past 3 years. Food and Drug Administration 4, 2020. However, in light of recent consumption [Docket No. FDA–2014–N–0487] ADDRESSES: To ensure that comments on of products from the SNS, we expect the information collection are received, future adjustments may be necessary Agency Information Collection OMB recommends that written and invite specific comment in this Activities; Submission for Office of comments be submitted to https:// regard. Management and Budget Review; www.reginfo.gov/public/do/PRAMain. Comment Request; Generic Clearance Find this particular information Dated: October 30, 2020. for the Collection of Qualitative collection by selecting ‘‘Currently under Lauren K. Roth, Feedback on Agency Service Delivery Review—Open for Public Comments’’ or Acting Principal Associate Commissioner for by using the search function. The OMB AGENCY: Food and Drug Administration, Policy. control number for this information HHS. [FR Doc. 2020–24427 Filed 11–3–20; 8:45 am] collection is 0910–0697. Also include ACTION BILLING CODE 4164–01–P : Notice. the FDA docket number found in brackets in the heading of this SUMMARY: The Food and Drug document. Administration (FDA) is announcing that a proposed collection of FOR FURTHER INFORMATION CONTACT: Ila information has been submitted to the S. Mizrachi, Office of Operations, Food Office of Management and Budget and Drug Administration, Three White (OMB) for review and clearance under Flint North, 10A–12M, 11601 the Paperwork Reduction Act of 1995. Landsdown St., North Bethesda, MD

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